Last Updated: May 23, 2026

Details for New Drug Application (NDA): 202123

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NDA 202123 describes COMPLERA, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the COMPLERA profile page.

The generic ingredient in COMPLERA is emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate profile page.

Summary for 202123

Tradename:	COMPLERA
Applicant:	Gilead Sciences Inc
Ingredient:	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate
Patents:	1

Pharmacology for NDA: 202123

Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 202123

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123	NDA	Gilead Sciences, Inc.	61958-1101	61958-1101-1	30 TABLET, FILM COATED in 1 BOTTLE (61958-1101-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG;EQ 25MG BASE;300MG
Approval Date:	Aug 10, 2011	TE:	AB	RLD:	Yes
Patent:	10,857,102	Patent Expiration:	Jan 14, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 202123

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	8,716,264	⤷ Start Trial
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	7,125,879	⤷ Start Trial
Gilead Sciences Inc	COMPLERA	emtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarate	TABLET;ORAL	202123-001	Aug 10, 2011	6,838,464	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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